Subject: The Oregon Health Authority, Public Health Division is permanently adopting and
amending Oregon Administrative Rules relating to in-home care agencies in response
to legislation passed in 2009 (SB 158) and 2011 (HB 2650). SB 158 attempts to correct
inadequate oversight due to gaps in law, inadequate resources, and clarifies statutes
governing the roles and responsibilities of many facilities and agencies providing
care to patients or clients. SB 158 also requires on-site surveys of all licensed
health care facilities and agencies at a minimum of every three years. HB 2650 repeals
provisions passed in 2009 requiring the Department of Human Services to conduct
criminal background checks for home health and in-home care agencies. Home health
and in-home care agencies may use private vendors to conduct criminal background
checks but must comply with the provisions of ORS 443.004. The Public Health Division
is required to prescribe the process for home health and in-home care agencies conducting
background checks.

Rules
Coordinator: Brittany Sande—(971) 673-1291

333-536-0000

Purpose

The purpose of
these rules is to establish standards for licensure of In-Home Care Agencies.

As used in OAR
333-536-0000 through 333-536-0125, the following definitions apply:

(1) “Abuse.”

(a) As
it applies to an adult, includes but is not limited to:

(A) Any
physical injury caused by other than accidental means, or that appears to be at
variance with the explanation given of the injury.

(B) Neglect
that leads to physical harm through withholding of services necessary to maintain
health and well-being.

(C) Abandonment,
including desertion or willful forsaking of a person or the withdrawal or neglect
of duties and obligations owed a person.

(D) Willful
infliction of physical pain or injury.

(E) Use
of derogatory or inappropriate names, phrases or profanity, ridicule, harassment,
coercion, threats, cursing, intimidation or inappropriate sexual comments or conduct
of such a nature as to threaten significant physical or emotional harm to a person.

(F) Wrongfully
taking or appropriating money or property, of knowingly subjecting a person to harm
by conveying a threat to wrongfully take or appropriate money or property, which
threat reasonably would be expected to cause the person to believe that the threat
will be carried out.

(G) Sexual
contact with a non-consenting person or with a person considered incapable of consenting
to a sexual act as described in ORS 163.315. As used in this paragraph, “sexual
contact” has the meaning given that term in ORS 163.305.

(b) As
is applies to a child, has the same meaning as “abuse” as that term
is defined in ORS 419B.005.

(2) “Activities
of daily living” means self-care activities that must be accomplished by an
individual to meet his or her daily needs.

(3) “Agency”
means In-Home Care Agency.

(4) “Branch
office” means a location or site from which an in-home care agency provides
services within a portion of the total geographic area served by the parent agency.
The site of the branch office generally does not exceed one hour of travel time
from the parent agency. The branch office is part of the in-home care agency and
is located sufficiently close to share administration, supervision, and services
in a manner that renders it unnecessary for the branch to independently meet the
requirements of an in-home care agency.

(5) “Caregiver”
means a person providing assistance with activities of daily living or assistance
with personal care tasks, household and supportive services, or medication services
as authorized by these rules.

(6) “Client
representative” means:

(a) A
parent, stepparent, foster parent, or other adult with primary caregiving responsibility
for the client when the client is a child; or

(b) An
individual, paid or unpaid, related or unrelated, who acts on behalf of, or cares
for the client when the client is an adult.

(7) “Division”
means the Public Health Division of the Oregon Health Authority.

(8) “Home
health agency” has the meaning given that term in ORS 443.005.

(9) “Hospice
program” has the meaning given that term in ORS 443.850.

(10) “In-home
care agency” means an agency primarily engaged in providing in-home care services
for compensation to an individual in that individual’s place of residence.
“In-home care agency” does not include a home health agency or portion
of an agency providing home health services as defined in ORS 443.005.

(11) “In-home
care services” means personal care services furnished by an in-home care agency,
or an individual under an arrangement or contract with an in-home care agency, that
are necessary to assist an individual in meeting the individual’s daily needs,
but do not include curative or rehabilitative services.

(12) “Licensed”
means that the person or agency for which the term applies is currently licensed,
certified, or registered by the proper authority within the State of Oregon.

(13) “Management
experience” means the administration, supervision or management of individuals
in a health related field including hiring, assigning, evaluating and taking disciplinary
actions.

(14) “Medication
administration” means administering medications to a client or directly supervising
the client who is not able or not willing to self-direct, but may be physically
able to perform the tasks. Medication administration includes but is not limited
to taking the client’s medications from original containers and putting the
medications into closed secondary containers designed and manufactured for this
purpose.

(15) “Medication
assistance” means helping the client who is able to self-direct with one or
more steps in the process of taking medication, but does not mean medication administration
as defined in these rules. Examples of medication assistance include, but are not
limited to, opening the medication container, helping the client self-administer
his or her medication, and assisting the client with one or more steps of medication
administration at the client’s direction.

(16) “Medication
reminding” means providing a client with an audio, visual or oral reminder
to take his or her medication when a client is able to self-direct.

(17) “Medication
services” means medication assistance or medication administration but does
not include medication reminding.

(18) “Nursing
services” means the provision of services that are deemed to be the practice
of nursing as defined by ORS 678.010. These services include but are not limited
to the delegation of specific tasks of nursing care to unlicensed persons in accordance
with the Oregon State Board of Nursing administrative rules, chapter 851, division
047. Nursing services are not rehabilitative or curative, but are maintenance in
nature.

(20) “Personal
care services” means the provision of or assistance with tasks intended to
supplement a client’s own personal abilities which are necessary to accomplish
the client’s activities of daily living and other activities as described
in OAR 333-536-0045(1), and are preventive and maintaining in nature.

(21) “Professional
experience” means having a nursing, medical, therapeutic license, certificate
or degree used to work in a health-related field or program or completion of a Division
approved training program.

(22) “Qualified
entity” means an entity whose training program has been approved by the Division.

(23) “Qualified
individual” means an individual who:

(a) Has
completed a Division approved training program; or

(b) Is
currently licensed as a registered nurse, practical nurse, physician assistant,
or pharmacist; or

(c) Is
another health care professional not listed in subsection (23)(b) who has been approved
by the Division to conduct training.

(25) “Schedule
caregivers” means to plan appointments for caregivers to deliver specific
in-home care services to clients; the times and dates of these appointments are
set by the in-home care agency.

(26) “Self-direct”
means to be oriented and to know:

(a) The
reason why each medication is taken, i.e. for what condition;

(b) The
amount or dose of medication that needs to be taken;

(c) The
route the medication needs to be taken; and

(d) The
time of day the medication needs to be taken.

(27) “Stable
and predictable” means a situation where the client’s clinical and behavioral
state is known, not characterized by rapid changes, and does not require continuous
reassessment and evaluation.

(28) “Subunit”
means an in-home care agency that provides for a parent agency in a geographic area
different from that of the parent agency and generally exceeding one hour of travel
time from the location of the parent agency.

(29) “Survey”
means an inspection of an applicant for an in-home care agency license or a licensed
in-home care agency to determine the extent to which the applicant or in-home care
agency is in compliance with state in-home care agency statutes and these rules.

(2) Medication
services training for caregivers employed by an agency classified as Basic, Intermediate
or Comprehensive shall be provided by a qualified individual or entity.

(3) Agencies
licensed by the Division must neither assume a descriptive title nor be held out
under any descriptive title other than the classification title established by the
Division and under which the agency is licensed. No agency licensed by the Division
shall provide services or use a classification title in its advertising, publicity,
or any other form of communication other than what the agency is licensed to provide.

(1) An agency
that establishes, conducts, or represents itself to the public as providing in-home
care services must be licensed by the Division and must comply with ORS 443.305
through 443.355 and these rules. The provisions of ORS 443.305 through 443.355 do
not apply to organizations licensed, registered or certified under ORS 101.030,
410.495, 443.410, 443.485, 443.725, 443.860, or 443.886. The provisions of ORS 443.305
through 443.355 do not apply to independent individuals, volunteers, family, neighbors,
or to agencies offering only housekeeping or on-call staffing for facilities, or
to support services provided and funded by the Department of Human Services. Entities
that provide referral or matching services that link in-home care services with
clients are not required to be licensed under these rules, unless they do one or
more of the following:

(a) Schedule
caregivers (as defined in OAR 333-536-0005);

(b) Assign
work;

(c) Assign
compensation rates;

(d) Define
working conditions;

(e) Negotiate
for a caregiver or client for the provision of services; or

(f) Place
a caregiver with a client.

(2) Application
for a license to operate an in-home care agency shall be in writing on a form provided
by the Division and shall include, but is not limited to, demographic, ownership
and administrative information about the agency.

(3) If
an owner or administrator has direct contact with a client, the owner or administrator
must submit background information to the Division in accordance with OAR 333-536-0093
for the purposes of conducting a criminal records check.

(4) If
any of the information delineated in an agency’s most recent application changes
at a time other than the annual renewal date, an agency shall submit a revised application
to the Division within 30 days of the change.

(a) An
agency that submits a revised application that contains a change to any of the following
must obtain Division approval prior to implementation:

(A) Administrator;

(B) Agency
classification;

(C) Branch
and subunit; and

(D) Geographic
service area exceeding one hour’s travel time.

(b) In
determining whether to grant approval for changes identified in subsection (4)(a)
of this rule, the Division may request agency documents or records for review to
determine compliance with in-home care licensing laws and rules, or may conduct
an on-site inspection.

(5) No
entity shall provide in-home care services or use the term “in-home care agency”
in its advertising, publicity, or any other form of communication unless it holds
a current valid license as an in-home care agency in accordance with the provisions
within.

Upon receipt
of a completed initial application and the required fee, the Division shall conduct
a survey in accordance with OAR 333-536-0041 of an agency or any subunit to determine
if an agency or subunit is in compliance with these rules and ORS 443.305 through
443.355, and has the intent to provide in-home care services.

Each license
to operate an in-home care agency shall expire twelve months from the date of issue.
If renewal is desired, the licensee shall make application at least 30 days prior
to the expiration date upon a form prescribed by the Division.

(1) The fee for
an initial in-home care agency license shall be $1,500. If the agency has subunits,
the fee for an initial license shall be $1,500 for the parent agency, plus an additional
$750 for each subunit.

(2) The
fee for a renewed in-home care agency license shall be $750. If the agency has subunits,
the fee for a renewed license shall be $750 for the parent agency, plus an additional
$750 for each subunit.

(3) If
the ownership of an agency changes other than at the time of the annual renewal,
the licensure fee shall be $350, plus an additional $350 for each subunit.

(1) A license
for an in-home care agency may be denied, suspended or revoked by the Division when
an in-home care agency has failed to comply with ORS 443.305 through 443.355 or
with OAR chapter 333, division 536, including but not limited to an owner or administrator
of the in-home care agency permitting, aiding or abetting any illegal act affecting
the welfare of the client.

(2) The
Division may deny, suspend or revoke the license of any in-home care agency for
failure to comply with ORS 443.004.

(3) A
failure to comply with ORS 443.305 through 443.355 includes but is not limited to:

(a) Failure
to provide a written disclosure statement to a client or a client’s representative
prior to in-home care services being rendered;

(b) Failure
to provide the contracted in-home care services; or

(c) Failure
to correct deficiencies identified during a Division inspection or complaint investigation.

(4) If
the Division intends to suspend or revoke an agency license, it shall do so in accordance
with ORS 183.411 through 183.470.

Each license
certificate in the licensee’s possession shall be returned to the Division
immediately upon the suspension or revocation of the license, failure to renew the
license by the date of expiration, or if operation is discontinued by the voluntary
action of the licensee.

(1) The Division
shall, in addition to any investigations conducted pursuant to OAR 333-536-0043,
conduct at least one survey of each in-home care agency prior to services being
rendered and once every three years thereafter as a requirement of licensing and
at such other times as the Division deems necessary.

(2) In
lieu of an on-site inspection required by section (1) of this rule, the Division
may accept a certification or accreditation from a federal agency or an accrediting
body approved by the Division that state licensing standards have been met if an
in-home care agency:

(a) Notifies
the Division to participate in any exit interview conducted by the federal agency
or accrediting body; and

(b) Provides
copies of all documentation concerning the certification or accreditation requested
by the Division.

(3) An
in-home care agency shall permit Division staff access to any location from which
it is operating its agency or providing services during a survey.

(5) An
in-home care agency shall make all requested documents and records available to
the surveyor for review and copying.

(6) Following
a survey, Division staff may conduct an exit conference with an agency owner, administrator,
or designee. During an exit conference, Division staff shall:

(a) Inform
the agency owner, administrator or designee of the preliminary findings of the inspection;
and

(b) Give
the owner, administrator or designee a reasonable opportunity to submit additional
facts or other information to the surveyor in response to those findings.

(7) Following
a survey, Division staff shall prepare and provide the agency owner or administrator
specific and timely written notice of the findings.

(8) If
the findings result in a referral to another regulatory agency, Division staff shall
submit the applicable information to that referral agency for its review and determination
of appropriate action.

(9) If
no deficiencies are found during a survey, the Division shall issue written findings
to the agency owner or administrator indicating that fact.

(10) If
deficiencies are found, the Division shall take informal or formal enforcement action
in accordance with OAR 333-536-0117 or 333-536-0120.

(1) Any person
may make a complaint verbally or in writing to the Division regarding an allegation
as to the care or services provided by an in-home care agency or violations of in-home
care agency laws or regulations.

(2) The
identity of a person making a complaint will be kept confidential.

(3) Information
obtained by the Division during an investigation of a complaint or reported violation
is confidential and not subject to public disclosure under ORS 192.410 through 192.505.

(4) Upon
conclusion of an investigation, the Division may publicly release a report of its
findings but may not include information in the report that could be used to identify
the complainant or any client of an in-home care agency. The Division may use any
information obtained during an investigation in an administrative or judicial proceeding
concerning the licensing of an in-home care agency.

(5) An
employee with knowledge of a violation of law or rules of the Division shall use
the reporting procedures established by an in-home care agency before notifying
the Division or other state agency of the inappropriate care or violation, unless
the employee:

(a) Believes
a client’s health or safety is in immediate jeopardy; or

(b) Files
a complaint in accordance with section (1) of this rule.

(6) If
a complaint involves an allegation of criminal conduct or an allegation that is
within the jurisdiction of another local, state, or federal agency, the Division
shall refer the matter to that agency.

(2) Should
the complaint allegation represent an immediate threat to the health or safety of
a client, the Division shall notify appropriate authorities to ensure a client’s
safety, and an investigation shall be commenced within two working days.

(3) An
agency shall permit Division staff access to the agency during an investigation.

(4) An
agency shall cooperate with investigations of allegations of client abuse and neglect
conducted by the Department of Human Services, Oregon Health Authority, Adult Protective
Services, and other agencies such as law enforcement.

(1) The services
provided by an agency must include the safe provision of or assistance with, personal
care tasks related to one or more of the following:

(a) Bathing;

(b) Personal
grooming and hygiene;

(c) Dressing;

(d) Toileting
and elimination;

(e) Mobility
and movement;

(f) Nutrition/hydration
and feeding;

(g) Medication
reminding.

(2) An
agency may provide medication reminding services for clients who can self-direct
as defined in OAR 333-536-0005 if the agency:

(a) Documents
the client’s knowledge of the following information using a standardized form
required by the Division:

(A) The
reason why each medication is taken;

(B) The
amount or dose of each medication that needs to be taken;

(C) The
route the medication needs to be taken; and

(D) The
time of day each medication needs to be taken.

(b) Retains
a copy of the standardized form, signed by the client, where an agency has determined
the client can self administer medications.

(3) An
agency must evaluate whether a client can continue to self-direct at a minimum of
every 90 days. If it is determined that a client can no longer self-direct, arrangements
shall be made to transfer the client to an agency with a higher license classification
within 30 days if the agency providing current services is not classified as such.

(4) All
documentation required in sections (2) and (3) of this rule shall be kept in the
client’s record.

(5) In
addition to personal care tasks, an agency may also provide one or more of the following
services upon approval by the Division:

(a) Non-injectable
medication assistance;

(b) Non-injectable
medication administration; or

(c) Nursing
services.

(6) An
agency may also provide housekeeping and other supportive services. Such tasks include,
but are not limited to:

(a) Housekeeping;

(b) Laundry;

(c) Shopping
and errands;

(d) Transportation;
and

(e) Arranging
for medical appointments.

(7) If
an agency has clients who receive only housekeeping and support services, the agency
is not required to comply with the following rules for those specific clients: OAR
333-536-0065, 333-536-0070, 333-536-0075, 333-536-0080, 333-536-0085 and 333-536-0090.

(8) Services
described in this rule shall be primarily provided at the client’s residence.
In addition, the services may be rendered at nonresidence locations as specified
in the client’s service plan.

(1) An agency
shall clearly set forth in writing the organization, services provided, administrative
control, and lines of authority and responsibility from the owner to the client-care
level.

(a) An
agency shall not assign administrative and supervisory functions to another agency
or organization.

(b) An
agency shall control and be responsible for all services provided.

(c) An
agency shall be required to maintain administrative and professional oversight to
ensure the quality of services provided.

(d) All
agency records must be kept separate and distinct from other business entities.

(2) Geographic
service area:

(a) An
agency shall identify in writing the geographic area in which it generally intends
to provide services.

(b) The
geographic service area shall be within a distance from a parent agency which ensures
appropriate and timely delivery and supervision of services with the following exception:

(A) An
agency caregiver may accompany a client outside the geographic service area if all
of the following conditions are met:

(i) A
client has requested an agency caregiver to accompany the client; and

(ii) The
travel plans are described and documented in a client’s service plan.

(B) An
agency shall require a caregiver who accompanies a client outside the geographic
service area to:

(i) Document
all services and care provided to the client on a daily basis;

(ii) Report
to the agency administrator or designee either by phone or e-mail the status of
the client before leaving the geographic service area and immediately upon return;

(iii)
Check-in with the agency administrator no less than once per week if the travel
results in the client and caregiver being gone for more than one week; and

(iv) Be
certified in Cardiopulmonary Resuscitation (CPR).

(C) If
the client’s condition changes while traveling, the caregiver must contact
the agency administrator or designee immediately.

(D) An
agency shall develop policies and procedures which address what caregivers must
do when their client’s condition changes while the client and caregiver are
out of the agency’s geographic service area.

(3) If
an agency operates a branch office:

(a) The
branch office shall be located within the parent agency’s geographic service
area at a distance from the parent agency that generally does not exceed one hour’s
travel time.

(b) The
branch office shall be operated under the management and supervision of the parent
agency. Administrative and personnel functions must be retained at the parent agency.
The branch office must not function as an independent agency.

(c) Services
must not be provided from the branch office until the branch office has been added
to the license of the parent agency in accordance with Division procedures.

(4) If
an agency provides services from an office generally exceeding one hour of travel
time located outside of a parent agency’s geographic service area, that office
will constitute a subunit of the agency. If the agency has subunits:

(a) The
subunit shall have its own staff, separate from parent agency staff, and shall operate
independently of the parent agency.

(b) The
subunit shall independently meet all licensing requirements, be separately licensed
from the parent agency, and pay a separate licensure fee.

(5) An
agency’s owner or designee shall:

(a) Assume
full legal, financial, and overall responsibility for the agency’s operation;
and

(b) Serve
as, or employ, a qualified administrator.

(6) An
administrator shall meet the following qualifications:

(a) Possess
a high school diploma or equivalent; and

(b) Have
at least two years of professional or management experience in a health-related
field or program or have completed a training program approved by the Division.

(7) An
administrator or designee shall be accessible and available during all hours in
which services are being provided to clients and must be able to be on site at the
parent agency location within a timely manner as needed. An administrator shall
assign, in writing, a qualified designee to act as administrator in his or her temporary
absence.

(8) An
administrator or designee shall be responsible for:

(a) Organizing
and directing the agency’s ongoing functions;

(b) Developing
and implementing written and current policies and procedures necessary to direct
the administrative, personnel, and client care operations of the agency, including
but not limited to the requirements in these rules;

(c) Ensuring
the completeness and accuracy of all information provided to the public regarding
the agency and its services;

(d) Ensuring
the provision of safe and appropriate services in accordance with written service
plans;

(e) Ensuring
that all individuals providing services for the agency meet the qualification, orientation,
competency, training, and education requirements in the rules;

(f) Ensuring
that personnel and client care practices are consistent with the agency’s
written policies and procedures.

(g) Ensuring
that client care assignments are based on the caregiver’s abilities, skills,
and competence;

(h) Ensuring
that the agency does not accept or retain clients for whom it does not have the
capabilities or resources to provide services;

(i) Ensuring
the timely internal investigation of complaints, grievances, accidents, incidents,
medication or treatment errors, and allegations of abuse or neglect involving individuals
providing services for the agency. An agency shall maintain in its records documentation
of the complaint or event, the investigation, the results, and actions taken;

(j) Ensuring
the timely reporting of allegations of abuse or neglect to the appropriate authority
that includes but is not limited to the Department of Human Services, Oregon Health
Authority, Public Health Division, or local law enforcement agency.

(9) Personnel
records for all caregiver, nursing staff, and employees shall include at a minimum
the following:

(a) Evidence
of pre-employment screening;

(b) Evidence
that the in-home care agency has conducted a criminal records check on all subject
individuals in accordance with OAR 333-536-0093.

(A) The
in-home care agency must ensure that a criminal records check has been conducted
on all subject individuals employed by or volunteering for an agency on or after
July 6, 2011.

(B) If
the screening indicates that a subject individual has been convicted for crimes
against an individual or property, the agency shall make a determination of the
individual’s fitness to provide care to clients in accordance with OAR 333-536-0093.

(c) Evidence
that all position qualifications have been met, including required licensure;

(1) When an individual
is accepted for agency service, a written disclosure statement shall be signed by
the client or the client’s representative. Evidence that the disclosure statement
was given to the client or the client’s representative shall be incorporated
into the client’s record.

(2) The
disclosure statement must include the following:

(a) A
description of the license classification and the services offered by the agency
according to OAR 333-536-0045, including the extent of registered nurse involvement
in the agency’s operations and whether nursing services as described in OAR
333-536-0080 are provided;

(b) If
the agency provides medication reminding or medication services, the qualifications
of the individual(s) providing oversight of the agency’s medication administration
systems and the medication training and demonstration;

(c) A
clear statement indicating that it is not within the scope of the agency’s
license to manage the medical and health conditions of clients who are no longer
stable or predictable;

(d) The
qualifications and training requirements determined by the agency for individuals
providing direct client care;

(e) The
charges for the services provided by the agency;

(f) A
description of how the service plans are developed and reviewed and the relationship
between the service plans and the cost of services;

(g) A
description of billing methods, payment systems, and due dates;

(h) The
policy for client notification of increases in the costs of services;

(i) The
agency’s refund policy;

(j) Criteria,
circumstances, or conditions which may result in termination of services by the
agency and client notification of such;

(k) Procedures
for contacting the agency administrator or designee during all of the hours during
which services are provided; and

(l) A
copy of the client’s rights as written in OAR 333-536-0060.

(3) An
agency administrator or designee shall conduct an initial screening to evaluate
a prospective client’s service requests and needs prior to accepting the individual
for service. The extent of the screening shall be sufficient to determine the ability
of the agency to meet those requests and needs based on the agency’s overall
service capability. The screening shall be documented, dated and signed by the individual
who conducted it.

(4) An
agency shall only accept or retain individuals for services for whom it can ensure
the following:

(a) The
agency has the capability to meet the in-home care needs of the individual;

(b) The
agency employs a sufficient number of trained and competent staff and has adequate
resources to provide the requested or needed services; and

(c) The
agency is able to coordinate its services with the care and services provided by
other organizations and individuals.

(5) The
agency shall notify the client, or the client’s representative, of the need
for a referral for medical or health services if the client’s medical or health
condition is no longer stable and predictable. The agency may continue to provide
in-home care services in the client’s residence, but must not manage, or represent
itself as able to manage a client’s medical or health condition that is not
stable and predictable.

(1) The agency
owner or administrator shall ensure that the agency recognizes and protects the
following rights of each client:

(a) The
right to be treated with dignity and respect;

(b) The
right to be free from theft, damage, or misuse of one’s personal property;

(c) The
right to be given the informed choice and opportunity to select or refuse service
and to accept responsibility for the consequences;

(d) The
right to be free from neglect of care, verbal, mental, emotional, physical, and
sexual abuse;

(e) The
right to be free from financial exploitation;

(f) The
right to be free from physical and chemical restraints;

(g) The
right to voice grievances or complaints regarding services or any other issue without
discrimination or reprisal for exercising such rights;

(h) The
right to be free from discrimination in regard to race, color, national origin,
gender, sexual orientation, or religion.

(i) The
right to participate in planning of the services and care to be furnished, any changes
in the services and care, the frequency of visits, and cessation of services;

(j) The
right to have access to his or her client record;

(k) The
right to have client information and records confidentially maintained by the agency;

(l) The
right to be advised in writing, before care is initiated, of the charges for the
services to be furnished, and the amount of payment that will be required from the
client;

(m) The
right to a written 30-day notice of termination of services by the agency that specifies
the reason(s) for the termination with the following exceptions:

(A) The
right to immediate oral or written notice of termination of services by the agency
at the time the agency determines that the safety of its staff or the client cannot
be ensured. If oral notice is given, the agency must also subsequently provide the
client a written confirmation of the oral notice of termination of services.

(B) The
right to a written 48-hour notice of termination of services by the agency in the
event of non-payment in accordance with the agency’s disclosed payment requirements.

(2) An
agency shall provide each client with a written notice of the client’s rights
as a part of the disclosure statement, prior to furnishing care to a client. The
client’s rights notice shall also include:

(a) Procedures
for filing a grievance or complaint with the agency;

(b) Procedures
for filing a grievance or complaint with the Division, along with the telephone
number and contact information of the Division; and

(c) Notice
that the Division has the authority to examine clients’ records as part of
the Division’s regulation and evaluation of the agency.

For clients receiving
services described in OAR 333-536-0045, the services provided shall be in accordance
with a written service plan developed in conjunction with a client or the client’s
representative based on the client’s or the client’s representative’s
request and an evaluation of the client’s physical, mental, and emotional
needs. The service plan must be consistent with the agency’s capabilities.

(1) The
agency administrator or designee shall conduct an initial evaluation of the client.
The evaluation must be documented, dated, and signed by the individual who conducted
the evaluation, and maintained in the client’s agency record.

(2) The
agency administrator or designee, in conjunction with the client or the client’s
representative, shall complete a written service plan within seven days after the
initiation of services. The agency administrator or designee shall ensure that the
service plan includes a list of individuals participating in development of the
plan. The agency administrator or designee shall also sign and date the service
plan when it is complete and acceptable to all individuals participating in development
of the plan.

(3) The
completed service plan shall be client-directed or client representative-directed
and include at least the following:

(a) The
schedule for the provision of services specifying a range of hours for services
per month;

(b) The
services to be provided, specifying the tasks to be conducted; and

(c) Pertinent
information about the client’s needs in relation to the services to be provided
to ensure the provision of safe and appropriate care.

(4) A
client or a client’s representative may request changes in the service plan.
All changes must be communicated to the caregiver(s) and documented.

(5) An
agency shall maintain the original service plan and all updated service plans in
each client’s agency record. Complete and legible copies of the service plan
shall be given to the client or client’s representative upon request.

(6) The
administrator or designee must conduct an initial visit at the client’s residence
within 30 days of the initiation of services to evaluate compliance by the caregiver(s)
with the service plan and to assess the client’s satisfaction. The initial
visit must occur between the 7th and 30th day. An initial visit is not required
when:

(a) A
client cancels service on or before the 30th day;

(b) A
client is residing in a nursing facility or a hospital; or

(c) A
client refuses.

(7) The
administrator or designee must conduct quarterly monitoring visits after the initial
site visit. Quarterly monitoring visits may occur by phone or by other electronic
means at the discretion of the administrator or designee under the following circumstances:
impending discharge from services; relocation to a facility; when minimal services,
such as one shift a month, would cause the client to incur undue financial burden;
or, due to other circumstances that are justified in chart note(s). In no case shall
the time between the in-person monitoring visits exceed a six-month period.

(8) Each
monitoring visit to observe and report on the client’s status must be documented,
dated, and signed by the administrator or designee. The caregiver may be present
during the monitoring visit.

(9) The
administrator or designee must determine and document during a monitoring visit:

(a) Whether
appropriate and safe techniques have been used in the provision of care;

(b) Whether
the service plan has been followed as written;

(c) Whether
the service plan is meeting the client’s needs or needs to be updated;

(d) Whether
the caregiver has received sufficient training for the client;

(e) Whether
the client is satisfied with his or her relationship with the caregiver(s); and

(f) Whether
appropriate follow-up is necessary for any identified issues or problems.

(10) If
services are provided in a non-residential setting in accordance with the service
plan, monitoring visits shall take place in the same setting that services are provided
and must conform to the requirements set forth in this rule.

The personal
care provided by an agency shall be rendered by qualified and trained employees
under the supervision of the administrator or designee. The services shall be provided
as requested by the client or client’s representatives in accordance with
these rules and the service plan.

(1) The
agency owner or administrator shall ensure that the agency has qualified and trained
employees sufficient in number to meet the needs of the clients receiving services.

(2) Caregivers
must be at least 18 years of age and shall have sufficient communication and language
skills to enable them to perform their duties and interact effectively with clients
and other agency staff.

(3) Caregivers
shall complete an agency-specific orientation, conducted by the agency administrator
or designee, before independently providing services to clients.

(a) The
orientation shall include, but not be limited to, the following subject areas:

(b) The
content of the training, the date(s) and length, and name(s) and signature(s) of
the instructor(s) shall be clearly documented for each caregiver and maintained
in personnel records.

(c) Caregivers
with proof of a current Oregon health-care related license or certificate are exempt
from in-home caregiver training.

(d) Caregivers
moving from one office to another in the same in-home care agency are not subject
to additional training requirements, provided previous training is documented.

(e) Caregivers
who have completed training previously, and have documentation of that training,
shall have their competency evaluated by an agency representative, and any potential
training may be limited to areas requiring improvement after the evaluation.

(f) Documentation
of training and competency evaluation shall be included in the caregiver’s
personnel record.

(5) Caregivers
shall receive a minimum of six hours of education related to caregiver duties annually.
If a caregiver provides medication administration to a client, one additional hour
of education shall be required annually related to providing medication administration.

(6) Caregiver
Selection and Review of Service Plan.

(a) The
skills of a caregiver must be matched with the care needs of a client. The administrator
or designee must assign caregivers to specific clients based on the care needs of
the clients and the skills of the caregivers.

(b) The
client’s service plan must be reviewed with each caregiver before the initial
delivery of client care. The date of the review(s), the signature or a unique electronic
identifier such as an individual’s log-in and password into a computer program
or an electronic stamp of the agency administrator or designee and the list of assigned
caregivers must be documented.

(c) Caregivers
must provide services to clients in accordance with the service plans.

(1) If an agency
has been approved to provide non-injectable medication services, the services shall
be rendered by persons who meet the requirements of section (10) of this rule. The
services shall be provided as requested by the client or client’s representatives
in accordance with these rules, accepted standards of medication practice, and the
service plan.

(2) If
a client representative or family member performs the task of filling secondary
non-injectable medication containers from which an agency caregiver is to administer
medication, an agency shall:

(a) Obtain
a signed agreement from the client representative or family member that identifies
their obligation to:

(A) Provide
a list of the client’s medication and a physical description of each with
any special instructions. The list must be updated when changes to the client’s
medication regimen are made;

(B) Keep
the original labeled medication containers in the home for verification should the
caregiver have questions; and

(C) Use
closed non-injectable medication secondary containers designed and manufactured
for that purpose that meet the labeling requirements of subsection (7)(d) of this
rule.

(3) Agency
staff shall obtain written or telephone orders from a physician or other legally
recognized practitioner for all medications managed or administered by an agency
under this rule and for any changes to those medications.

(a) Written
orders shall be signed or confirmed by a physician or practitioner.

(b) Telephone
orders shall be immediately recorded, dated, and signed by agency staff, and transmitted
within 72 hours to the physician or practitioner for confirmation. The orders that
have been signed or confirmed by the physician or practitioner shall be incorporated
into the client’s record within 30 days.

(4) An
agency owner or administrator shall be responsible for developing and implementing
safe and appropriate medication administration delivery systems and policies and
procedures that include, but are not limited to:

(a) Provisions
to ensure that each client receives the right medication, in the right amount, by
the right route, and at the right time;

(b) Provisions
to ensure that the caregivers are informed about the potential adverse reactions,
side effects, drug-to-drug interactions and food-to-drug interactions, and contraindications
associated with each client’s medication regimen;

(c) Provisions
to ensure that the caregivers promptly report problems or discrepancies related
to each client’s medication regimen to the caregivers’ supervisor, agency
administrator or designee;

(d) Provisions
to ensure storage of medications at appropriate temperatures based on the manufacturer’s
recommendations; and

(e) Provisions
to ensure the security and integrity of narcotics and controlled substances.

(5) A
client’s service plan must specify the medication tasks to be performed.

(6) Records
for medication administration shall include, but are not limited to, the name of
each medication, the dosage to be administered, the route of administration, the
frequency of administration, client medication allergies and sensitivities, client
specific indicators for administration of as needed medications and other special
instructions necessary for safe and appropriate administration.

(7) Packaging
and labeling:

(a) Prescription
medications shall be in the original pharmacy containers and clearly labeled with
the pharmacists’ labels.

(b) Samples
of medications received from the physician or practitioner shall be in the original
containers and have the original manufacturers’ labels.

(c) Over-the-counter
medications shall be in the original containers and have the original manufacturers’
labels.

(d) Secondary
containers and all removable compartments must be labeled with the client’s
name, the specific time the medications in each compartment are to be administered,
the date and time the secondary container was filled, and the name of the individual
who filled the container.

(e) Liquid
and non-pill medications that cannot be put in secondary containers shall be appropriately
labeled.

(8) The
provision of medication tasks as described in this rule shall be documented by the
individuals performing the tasks. The documentation shall include the tasks completed,
the date and signature of the individual(s) performing the task(s), and shall be
maintained in accordance with agency policies and procedures.

(9) Visits
by a registered nurse to evaluate a client’s medication regimen and the provision
of medication administration services shall be conducted and documented at least
every 90 days for each client receiving medication administration services.

(10) Agency
caregivers assigned to provide medication services must be given basic non-injectable
medication training before providing the services. The medication training must
include successful return demonstrations of non-injectable medications tasks by
the caregivers.

(a) The
medication training shall include at least the following areas:

(A) Medication
abbreviations;

(B) Reading
medication orders and directions;

(C) Reading
medication labels and packages;

(D) Setting
up medication labels and packages;

(E) Administering
non-injectable medications:

(i) Pill
forms, including identification of pills that cannot be crushed;

(ii) Non-injectable
liquid forms, including those administered by syringe or dropper and eye and ear
drops;

(b) Prior
to providing medication services, caregivers shall demonstrate appropriate and safe
techniques in the provision of medication tasks described in this rule.

(c) The
content of the medication training, the dates and length of training, the identity
of the qualified individual or qualified entity, evidence of successful return demonstrations,
and the instructor’s statement that the caregiver has been evaluated to be
competent to provide the medication services described in this rule shall be clearly
documented for each caregiver and maintained in the agency’s personnel records.

(d) An
individual with a current Oregon State Board of Nursing medication aide (CMA) certification
is exempt from the training requirements in this rule.

(1) If an agency
has been approved to provide nursing services, the services must be provided by
an Oregon-licensed registered nurse employed by the agency and provided only to
a client whose medical condition and health status is stable and predictable. The
services shall be provided as requested by a client or a client’s representative
and shall be in accordance with these rules, the applicable administrative rules
of the Oregon State Board of Nursing (OAR chapter 851, division 047), and the service
plan.

(2) Delegation
of specific tasks of nursing care to unlicensed persons shall be conducted and documented
by the registered nurse as required by the Oregon State Board of Nursing administrative
rules chapter 851, division 047. A client’s record shall contain documentation
that all requirements within those rules have been met, including but not limited
to: assessment, instruction, observation, supervision, and re-evaluation.

(3) A
client’s service plan shall include current identification of the delegated
specific task(s) of nursing care to be provided and shall specify the caregivers
to whom the task(s) have been delegated.

(4) The
provision of nursing services as described in this rule shall be documented by the
individual(s) providing the service(s) or performing the task(s). The documentation
shall include the services(s) or task(s) completed, the date and signature of the
individual(s) performing the service(s) or task(s), and shall be maintained in accordance
with an agency’s policies and procedures.

(5) For
all medications and medical treatments managed or administered by an agency under
this rule, and for any changes to those medications or medical treatments, a registered
nurse shall obtain written or telephone orders from a physician or other legally
recognized practitioner.

(a) Written
orders shall be signed or confirmed by a physician or practitioner.

(b) Telephone
orders shall be immediately recorded, dated, and signed by the registered nurse,
and transmitted within 72 hours to the physician or practitioner for confirmation.
The orders that have been signed or confirmed by the physician or practitioner shall
be incorporated into the client’s record within 30 days.

(1) A client
record shall be maintained for every client served by an agency, unless the client
receives only housekeeping or support services, and shall be maintained in the agency’s
office.

(2) A
legible, reproducible client record shall include at least the following:

(a) Identification
data;

(b) Referral
and intake information;

(c) Start-of-service
date;

(d) Screening
and disclosure documents and documentation required by these rules;

(e) Clients’
rights documentation required by these rules;

(f) All
client evaluation and assessment documentation;

(g) Client
service plan and updates;

(h) Documentation
of all services provided;

(i) Service
and financial agreement signed by a client or a client’s representative before
the initiation of services that specifies the services to be provided in accordance
with the service plan, and the costs for those services;

(j) End-of-services
date; and

(k) End-of-service
summary, including the dates of service and the disposition of the client.

(3) All
entries and documents in the record must be recorded in ink, typescript, or computer-generated.

(4) All
entries in a client’s record must be dated and signed, or otherwise authenticated
by the person making the entry. For purposes of this rule, authenticated means verification
by the author that an entry in the client record is genuine. Electronic authentication
is acceptable as long as there is a process for reconstruction of the information
and there are safeguards to prevent unauthorized access to the records.

(5) A
client record shall be maintained in a manner that renders it easily retrievable.

(6) Reasonable
precautions must be taken to protect a client’s record and information from
unauthorized access, fire, water, and theft.

(7) In
an effort to coordinate services and care with other providers, including but not
limited to, hospice, home health, and family members, as required in OAR 333-536-0055(4)(c),
charting notes within a client’s home may be shared, as permitted by law.

(8) Authorized
employees of the Division shall be permitted to review client records upon request.
Photocopies of the records shall be made upon request.

(9) All
clients’ records shall be kept for a period of at least seven years after
the date of last end-of-service.

(10) Clients’
records are the property of the agency.

(11) If
an agency changes ownership, all clients’ records shall remain in the agency,
and it shall be the responsibility of the new owner to protect and maintain these
records.

(12) Before
an agency terminates its business, the agency shall notify the Division where the
clients’ records will be stored.

An agency shall
establish and maintain an effective, agency wide quality assessment and performance
improvement program that evaluates and monitors the quality, safety and appropriateness
of services provided by the agency, and shall include at a minimum:

(1) A
method to identify, analyze and correct adverse events;

(2) A
method to select and track quality indicators by high risk, high volume, problem
prone areas and by the effect on client safety and quality of care;

(3) The
quality improvement activities shall be conducted by a committee comprised of, at
a minimum, agency administrative staff, an agency caregiver, and if the agency is
classified as an intermediate or comprehensive agency, an agency registered nurse;
and

(1) For the purposes
of this section, the following definitions apply:

(a) “Direct
contact with” means to provide in-home care services and includes meeting
in person with a potential or current client to discuss services offered by an agency
or other matters relating to the business relationship between an agency and client;

(b) “Disqualifying
condition” means a non-criminal personal history issue that makes an individual
unsuitable for employment, contracting or volunteering for an agency, including
but not limited to discipline by a licensing or certifying agency, or drug or alcohol
dependency;

(c) “Subject
individual” (SI) means an individual on whom an agency may conduct a criminal
records check and from whom an agency may require fingerprints for the purpose of
conducting a national criminal records check, including:

(A) An
employee or prospective employee;

(B) A
temporary worker, volunteer or owner of an agency who has direct contact with an
agency client or potential client; and

(C) A
prospective temporary worker, or volunteer or owner who may have direct contact
with an agency client.

(d) “Vendor”
means a researcher or company hired to provide a criminal records check on a subject
individual.

(e) “Weighing
test” means a process in which an agency considers available information to
make a fitness determination when an SI has potentially disqualifying convictions
or conditions.

(2) An
agency shall conduct a criminal records check before hiring an SI and before allowing
an SI to volunteer to provide services on behalf of the agency, if an SI will have
direct contact with a client of the agency.

(3) An
SI who has or will have direct contact with a recipient of in-home care services
may not be employed or volunteer with an agency in any capacity if the criminal
records check conducted reveals the SI has been convicted of a crime as described
in ORS 443.004(3).

(4) An
agency shall have a policy on criminal records check requirements that shall include
weighing test actions should the records check screening indicate that an SI has
been convicted for crimes against an individual or property other than those identified
in ORS 443.004(3). The policy must include the following provisions for performing
a weighing test:

(a) The
agency shall consider circumstances regarding the nature of potentially disqualifying
convictions and conditions including but not limited to:

(A) The
details of incidents leading to the charges of potentially disqualifying convictions
or resulting in potentially disqualifying conditions;

(B) The
age of the SI at the time of the potentially disqualifying convictions or conditions;

(C) Facts
that support the convictions or potentially disqualifying conditions; and

(D) Passage
of time since commission of the potentially disqualifying convictions or conditions.

(b) Other
factors that should be considered when available include but are not limited to:

(A) Other
information related to criminal activity including charges, arrests, pending indictments
and convictions. Other behavior involving contact with law enforcement may also
be reviewed if information is relevant to other criminal records or shows a pattern
relevant to criminal history;

(B) Periods
of incarceration;

(C) Status
of and compliance with parole, post-prison supervision or probation;

(E) Evidence
of other treatment or rehabilitation related to criminal activity or potentially
disqualifying conditions;

(F) Likelihood
of repetition of criminal behavior or behaviors leading to potentially disqualifying
conditions, including but not limited to patterns of criminal activity or behavior;

(G) Changes
in circumstances subsequent to the criminal activity or disqualifying conditions
including but not limited to:

(i) History
of high school, college or other education related accomplishments;

(ii) Work
history (employee or volunteer);

(iii)
History regarding licensure, certification or training for licensure or certification;
or

(iv) Written
recommendations from current or past employers;

(H) Indication
of the SI’s cooperation, honesty or the making of a false statement during
the criminal records check process, including acknowledgment and acceptance of responsibility
of criminal activity and potentially disqualifying conditions.

(c) An
agency shall consider the relevancy of an SI’s criminal activity or potentially
disqualifying conditions to the paid or volunteer position, or to the environment
in which the SI will work, especially, but not exclusively:

(A) Access
to medication;

(B) Access
to clients’ personal information;

(C) Access
to vulnerable populations.

(5) An
agency shall document the weighing test and place in the employee’s file.

(6) A
criminal records check shall be performed by:

(a) The
Department of Human Services, Background Check Unit; or

(b) A
vendor that:

(A) Is
accredited by the National Association of Professional Background Screeners (NAPBS);
or

(B) Meets
the following criteria:

(i) Has
been in business for at least two years;

(ii) Has
a current business license and private investigator license, if required in the
company’s home state; and

(iii)
Maintains an errors and omissions insurance policy in an amount not less than $1
million.

(7) An
agency may use the Oregon State Police, Open Records Unit in order to fulfill the
state records requirement for a criminal records check, however, an agency must
still complete a nationwide check through a qualified vendor.

(8) A
criminal records check must include the following:

(a) Name
and address history trace;

(b) Verification
that the SI’s records have been correctly identified, via date of birth check
and Social Security number trace;

(c) A
local criminal records check, including city and county records for SI’s places
of residence for the last seven years;

(d) A
nationwide multijurisdictional criminal database search, including state and federal
records;

(e) A
nationwide sex offender registry search;

(f) The
name and contact information of the vendor who completed the records check;

(g) Arrest,
warrant and conviction data, including but not limited to:

(A) Charge(s);

(B) Jurisdiction;
and

(C) Date.

(h) Source(s)
for data included in the report.

(9) An
agency shall perform and document a query of an SI with the National Practitioner
Data Bank (NPDB) and the List of Excluded Individuals and Entities (LEIE).

(10) All
criminal records checks conducted under this rule shall be documented in writing
and made part of the agency’s personnel files.

(11) An
agency that has a contract with the Department or Authority for the provision of
in-home care services on or after July 1, 2012 and who is subject to the Department’s
criminal records check rules does not have to comply with section (12) of this rule.

(12) For
an SI hired to work or volunteer for an agency on or after July 6, 2011, an agency
shall have until October 1, 2012 to ensure that the agency is in compliance with
section (3) of this rule.

(13) On
or after July 1, 2012 an agency shall ensure that a criminal records check is performed
on an SI every three years from the date of the SI’s last criminal records
check in accordance with these rules.

(14) Notwithstanding
sections (12) and (13) of this rule, the Division and not the agency shall conduct
a criminal records check on an owner or administrator of any agency who is subject
to a criminal records check under subsection (1)(c) of this rule. The Division shall
conduct a criminal records check:

(a) At
the time of application for a person who applies for a license on or after July
1, 2012 and every three years thereafter.

(b) By
July 1, 2013 for an agency that is licensed on or before July 1, 2012, and every
three years thereafter.

(1) While all
agencies are required to maintain continuous compliance with the Division’s
rules, these requirements do not prohibit the use of alternative concepts, methods,
procedures, techniques, equipment, facilities, personnel qualifications or the conducting
of pilot projects or research. Requests for exceptions to the rules must:

(a) Be
submitted to the Division in writing;

(b) Identify
the specific rule for which an exception is requested;

(c) Indicate
the special circumstances relied upon to justify the exception;

(d) Identify
what alternatives were considered, if any, and why alternatives (including compliance)
were not selected;

(e) Demonstrate
that the proposed exception is desirable to maintain or improve the health and safety
of the clients, and will not jeopardize client health and safety; and

(f) Identify
the proposed duration of the exception.

(2) Upon
finding that an agency has satisfied the condition of this rule, the Division may
grant an exception.

(3) An
agency may implement an exception only after receipt of written approval from the
Division.

(1) If during
an investigation or survey Division staff document violations of in-home care licensing
rules or laws, the Division may issue a statement of deficiencies that cites the
law or rule alleged to have been violated and the facts supporting the allegation.

(2) Upon
receipt of a statement of deficiencies, an agency shall be provided an opportunity
to dispute the Division’s survey findings but must still comply with sections
(3) and (4) of this rule.

(a) If
an agency desires an informal conference to dispute the Division’s survey
findings, the agency shall advise the Division in writing within 10 business days
after receipt of the statement of deficiencies. The written request must include
a detailed explanation of why the agency believes the statement of deficiencies
is incorrect.

(b) An
agency may not seek a delay of any enforcement action against it on the grounds
the informal dispute resolution has not been completed.

(c) If
an agency is successful in demonstrating the deficiencies should not have been cited,
the Division shall reissue the statement of deficiencies, removing such deficiencies
and rescinding or modifying any remedies issued for such deficiencies. The reissued
statement of deficiencies shall state that it supersedes the previous statement
of deficiencies and shall clearly identify the date of the superseded statement
of deficiencies.

(3) A
signed plan of correction must be mailed to the Division within 10 business days
from the date the statement of deficiencies was received by the agency. A signed
plan of correction will not be used by the Division as an admission of the violations
alleged in the statement of deficiencies.

(4) An
agency shall correct all deficiencies within 60 days from the date of the exit conference,
unless an extension of time is requested from the Division. A request for such an
extension shall be submitted in writing and must accompany the plan of correction.

(5) The
Division shall determine if a written plan of correction is acceptable. If the plan
of correction is not acceptable to the Division, the Division shall notify the agency
owner or administrator in writing:

(a) Identifying
which provisions in the plan the Division finds unacceptable;

(b) Citing
the reasons the Division finds the provisions unacceptable; and

(c) Requesting
that the plan of correction be modified and resubmitted no later than 10 business
days from the date notification of non-compliance was received by the agency owner
or administrator.

(6) If
the agency does not come into compliance by the date of correction reflected on
the plan of correction or 60 days from the date of the exit conference, whichever
is sooner, the Division may propose to deny, suspend or revoke the agency license
or impose civil penalties.

(1) If during
an investigation or survey Division staff document a substantial failure to comply
with in-home care licensing laws or rules, or if an agency fails to pay a civil
penalty imposed under ORS 443.325 and these rules, the Division may issue a Notice
of Proposed Suspension or Notice of Proposed Revocation in accordance with ORS 183.411
through 183.470.

(2) The
Division may issue a Notice of Imposition of Civil Penalty for violations of in-home
care licensing laws.

(3) At
any time the Division may issue a Notice of Emergency License Suspension under ORS
183.430(2).

(4) If
the Division revokes an agency license, the order shall specify when, if ever, the
agency may reapply for a license.

(5) The
Division may reissue an agency license that has been suspended or revoked after
the Division determines that compliance with these rules has been achieved.

(1) An agency
that violates in-home care laws or rules, an administrative order, or settlement
agreement is subject to the imposition of a civil penalty not to exceed $1,000 per
violation and may not total more than $2,000.

(2) An
individual who operates an in-home care agency without a license is subject to the
imposition of a civil penalty not to exceed $500 a day per violation.

(3) In
determining the amount of a civil penalty, the Division shall consider whether:

(a) The
Division made repeated attempts to obtain compliance;

(b) The
licensee has a history of non-compliance with in-home care licensing laws and rules;

(c) The
violation poses a serious risk to the public’s health; and

(d) There
are mitigating factors, such as a licensee’s cooperation with an investigation
or actions to come into compliance.

(4) The
Division shall document its consideration of the factors in section (2) of this
rule.

(5) Each
day a violation continues is an additional violation.

(6) A
civil penalty imposed under this rule shall comply with ORS 183.746.

(7) Failure
to comply with ORS 443.305 through 433.355 includes but is not limited to:

(a) Failure
to provide a written disclosure statement to the client or the client’s representative
prior to in-home care services being rendered;

(b) Failure
to provide the contracted in-home care services; or

(c) Failure
to correct deficiencies identified during a Division inspection or complaint investigation.

Rule Caption: Drug Shortages and Use of
Expired Medications for Ambulance Services.

Adm. Order
No.: PH 11-2012(Temp)

Filed
with Sec. of State: 6-26-2012

Certified
to be Effective: 7-1-12 thru 12-27-12

Notice
Publication Date:

Rules
Adopted: 333-250-0051

Subject: The Oregon Health Authority, Public Health Division is temporarily adopting OAR
333-250-0051 relating to drug shortages and the use of expired pharmacological and
medical supplies in ambulance services. The U.S. Food and Drug Administration has
reported that drug shortages have been increasing in frequency and severity in recent
years and the number of reported prescription drug shortages in the United States
nearly tripled between 2005 and 2010, going from 61 to 178. Shortages can occur
for many reasons, including manufacturing and quality problems, delays, and discontinuations
of products. Emergency medical services (EMS) providers in Oregon may periodically
be unable to obtain necessary and sometimes life-saving pharmacological and medical
supplies due to national or regional shortages. Currently, ambulance services are
prohibited from carrying expired pharmacological and medical supplies. The intent
of this temporary rule is to provide that an ambulance service will not be subject
to discipline for retaining expired pharmacological or medical supplies when certain
standards are met. By adopting this temporary rule an ambulance service may carry
expired pharmacological and medical supplies and use them, at the direction of a
medical director, if not providing the drug would adversely affect patient care
or if necessary to potentially save a patient’s life.

(1) An ambulance
service will not be subject to discipline for retaining expired pharmacological
or medical supplies in violation of OAR 333-250-0049(2)(c) if an ambulance service
documents the following:

(a) Contact
information, including the date of contact, for three sources from which the ambulance
service or its designee attempted to obtain the pharmacological or medical supplies,
including but not limited to distributors, other health care providers, compounding
pharmacies, or any other reseller that could reasonably be expected to be able to
sell agents to the ambulance service;

(b) A
written finding by the medical director that a substitution for the pharmacological
or medical supply that is expired is unavailable or would pose a greater risk to
a patient than use of an expired medication; and

(c) A
copy of the directive or training provided to Emergency Medical Services Providers
(EMS Providers) about the circumstances under which they are authorized to use an
expired pharmacological or medical supply.

(2) The
individual responsible for administering the agency’s emergency medical services
program must sign a statement attesting to the following: “I attest that I
have made a good-faith effort to obtain [name of the pharmacological or medical
supply] from the sources described herein for use by [Ambulance Provider], but was
unable to obtain it. I have issued instructions or training described herein to
EMS Providers on using expired pharmacological and medical supplies”.

(3) The
documentation required in this rule must be maintained in the records of the ambulance
service and made available to Oregon Health Authority upon request.

(4) An
EMS Provider may only use an expired pharmacological or medical supply if approved
by the EMS Provider’s medical director.

Notes1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2011.